- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01078168
Alzheimer's Disease Acitretin Medication (ADAM)
July 18, 2017 updated by: K. Lieb
Changes of Cerebral Spinal Fluid APPSα Levels Under Oral Therapy With Acitretin 30 mg Daily in Patients With Mild to Moderate Alzheimer's Disease: a Multicenter Prospective Randomised Placebo-controlled Parallel-group Study
The trials investigates the changes of cerebral spinal fluid (CSF) soluble alpha-secretase cleaved APP (APPsα) levels under oral therapy with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease (AD).The present study aims to demonstrate an enhancement of the α-secretase activity by acitretin as measured by increased CSF APPSα levels in human AD.
Second, the safety and tolerability of acitretin in AD patients should be proven.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Rostock, Germany, 18057
- Universität Rostock
-
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Germany, 55131
- Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- mild to moderate AD (NINCDS-ADRDA criteria)
- Mini-Mental State Examination (MMSE): 27-14 points
- Geriatric Depression Scale ≤ 14
Exclusion Criteria:
- hereditary cognitive impairment
- known history of brain injuries
- Insufficient German language skills
- actual treatment with other potential disease modifying drugs of AD
- multimorbidity or significant organ (esp. liver or renal) dysfunction
- evidence of Non-AD neurodegenerative disorder (e.g. Parkinson)
- contraindication to acitretin such as osteoporosis, hypoalbuminaemia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Acitretin
oral, 30 mg per day, day 1-28
|
30mg per day from Day 1 to Day 28
Other Names:
|
Placebo Comparator: Placebo
oral, day 1-28
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Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline
Time Frame: baseline and 4 weeks (visit 3)
|
Values were assessed via Western blotting technique.
Normalization was conducted using hSA levels of the individual samples.
|
baseline and 4 weeks (visit 3)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andreas Fellgiebel, PD Dr., Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
March 1, 2010
First Submitted That Met QC Criteria
March 1, 2010
First Posted (Estimate)
March 2, 2010
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
July 18, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADAM
- 2009-011881-27 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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